[Federal Register Volume 84, Number 222 (Monday, November 18, 2019)]
[Notices]
[Pages 63661-63662]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-24921]



[[Page 63661]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-4992]


Pan American Laboratories, LLC, et al.; Proposal To Withdraw 
Approval of Four New Drug Applications; Opportunity for a Hearing

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration's (FDA or Agency) Center for 
Drug Evaluation and Research (CDER) is proposing to withdraw approval 
of four new drug applications (NDAs) from multiple NDA holders and is 
announcing an opportunity for the NDA holders to request a hearing on 
this proposal. The basis for the proposal is that the NDA holders have 
repeatedly failed to file required annual reports for these NDAs.

DATES: The NDA holders may submit a request for a hearing by December 
18, 2019. Submit all data, information, and analyses upon which the 
request for a hearing relies January 17, 2020. Submit electronic or 
written comments by January 17, 2020.

ADDRESSES: The request for a hearing may be submitted by the NDA 
holders by either of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments to submit your request 
for a hearing. Comments submitted electronically to https://www.regulations.gov, including any attachments to the request for a 
hearing, will be posted to the docket unchanged.

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     Because your request for a hearing will be made public, 
you are solely responsible for ensuring that your request does not 
include any confidential information that you or a third party may not 
wish to be posted, such as medical information, your or anyone else's 
Social Security number, or confidential business information, such as a 
manufacturing process. The request for a hearing must include the 
Docket No. FDA-2019-N-4992 for ``Pan American Laboratories, LLC, et 
al.; Proposal To Withdraw Approval of Four New Drug Applications; 
Opportunity for a Hearing.'' The request for a hearing will be placed 
in the docket and publicly viewable at https://www.regulations.gov or 
at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday 
through Friday.
    The NDA holders may submit all data and analyses upon which the 
request for a hearing relies in the same manner as the request for a 
hearing except as follows:
     Confidential Submissions--To submit any data analyses with 
confidential information that you do not wish to be made publicly 
available, submit your data and analyses only as a written/paper 
submission. You should submit two copies total of all data and 
analyses. One copy will include the information you claim to be 
confidential with a heading or cover note that states ``THIS DOCUMENT 
CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, 
including the claimed confidential information, in its consideration of 
any decisions on this matter. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov 
or available at the Dockets Management Staff between 9 a.m. and 4 p.m., 
Monday through Friday. Submit both copies to the Dockets Management 
Staff. Any information marked as ``confidential'' will not be disclosed 
except in accordance with 21 CFR 10.20 and other applicable disclosure 
law.
    Comments Submitted by Other Interested Parties: For all comments 
submitted by other interested parties, submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2019-N-4992 for ``Pan American Laboratories, LLC, et al.; Proposal 
To Withdraw Approval of Four New Drug Applications; Opportunity for a 
Hearing.'' Received comments, those filed in a timely manner (see DATE  
), will be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked

[[Page 63662]]

as ``confidential'' will not be disclosed except in accordance with 21 
CFR 10.20 and other applicable disclosure law. For more information 
about FDA's posting of comments to public dockets, see 80 FR 56469, 
September 18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Kimberly S. Lehrfeld, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993-0002, 301-
796-3137.

SUPPLEMENTARY INFORMATION: The holders of approved applications to 
market new drugs for human use are required to submit annual reports to 
FDA concerning each of their approved applications in accordance with 
Sec.  314.81 (21 CFR 314.81). The NDA holders listed in table 1 have 
failed to submit the required annual reports and have not responded to 
the Agency's request for submission of the reports.

     Table 1--Approved NDAs for Which Required Reports Have Not Been
                                Submitted
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     Application No.               Drug                 NDA holder
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NDA 014217..............  MAOLATE (chlorphenesin  Pan American
                           carbamate) Tablet,      Laboratories, LLC,
                           400 milligrams (mg).    4099 Highway 190,
                                                   Covington, LA 70433.
NDA 018663..............  CHYMODIACTIN            Chart Medical, Inc., c/
                           (chymopapain) for       o Renascent Medical,
                           Injection, 4,000        Inc., 9600 Great
                           Units/vial and 10,000   Hills Trail, Suite
                           Units/vial.             150 West, Austin, TX
                                                   78759.
NDA 020530..............  IONTOCAINE              Iomed, Inc., 2441
                           (epinephrine and        South 3850 West,
                           lidocaine               Suite A, Salt Lake
                           hydrochloride (HCl))    City, UT 84120-9941.
                           Topical Solution,
                           0.01 mg/milliliter;
                           2%.
NDA 021504..............  LIDOSITE TOPICAL        Vyteris, Inc., 13-01
                           SYSTEM: LidoSite        Pollitt Dr., Fair
                           Patch (lidocaine HCl    Lawn, NJ 07410.
                           and epinephrine
                           topical iontophoretic
                           patch) 10%/0.1% and
                           LidoSite Controller.
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    Therefore, notice is given to the NDA holders listed in table 1 and 
to all other interested persons that the Director of CDER proposes to 
issue an order under section 505(e) of the Federal Food, Drug, and 
Cosmetic Act (FD&C Act) (21 U.S.C. 355(e)), withdrawing approval of the 
applications and all amendments and supplements thereto on the grounds 
that the NDA holders have failed to submit reports required under Sec.  
314.81.
    In accordance with section 505 of the FD&C Act and 21 CFR part 314, 
the NDA holders are hereby provided an opportunity for a hearing to 
show why the approval of the applications listed previously should not 
be withdrawn and an opportunity to raise, for administrative 
determination, all issues relating to the legal status of the drug 
products covered by these applications.
    An NDA holder who decides to seek a hearing must file the 
following: (1) A written notice of participation and request for a 
hearing (see DATES and ADDRESSES) and (2) the data, information, and 
analyses relied on to demonstrate that there is a genuine and 
substantial issue of fact that requires a hearing (see DATES and 
ADDRESSES). Any other interested person may also submit comments on 
this notice. The procedures and requirements governing this notice of 
opportunity for a hearing, notice of participation and request for a 
hearing, information and analyses to justify a hearing, other comments, 
and a grant or denial of a hearing are contained in Sec.  314.200 (21 
CFR 314.200) and in 21 CFR part 12.
    The failure of an NDA holder to file a timely written notice of 
participation and request for a hearing, as required by Sec.  314.200, 
constitutes an election by that NDA holder not to avail itself of the 
opportunity for a hearing concerning CDER's proposal to withdraw 
approval of the applications and constitutes a waiver of any 
contentions concerning the legal status of the drug products. FDA will 
then withdraw approval of the applications, and the drug products may 
not thereafter be lawfully introduced or delivered for introduction 
into interstate commerce. Any new drug product introduced or delivered 
for introduction into interstate commerce without an approved 
application is subject to regulatory action at any time.
    A request for a hearing may not rest upon mere allegations or 
denials, but must present specific facts showing that there is a 
genuine and substantial issue of fact that requires a hearing. If a 
request for a hearing is not complete or is not supported, the 
Commissioner of Food and Drugs will enter summary judgment against the 
person who requests the hearing, making findings and conclusions, and 
denying a hearing.
    All submissions under this notice of opportunity for a hearing must 
be filed in four copies. Except for data and information prohibited 
from public disclosure under 21 U.S.C. 331(j) or 18 U.S.C. 1905, the 
submissions may be seen at the Dockets Management Staff (see ADDRESSES) 
between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to 
the docket at https://www.regulations.gov.
    This notice is issued under section 505(e) of the FD&C Act and 
under authority delegated to the Director of CDER by the Commissioner 
of Food and Drugs.

    Dated: November 12, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-24921 Filed 11-15-19; 8:45 am]
 BILLING CODE 4164-01-P